What is Qualification :
The act of planning, carrying out and recording the results of tests on equipment’s and system to confirm its capabilities and to demonstrate that it will perform consistently as intended use and against predefined specification.
General requirements :
premises, systems, utilities and equipment should be appropriately designed, installed, qualified, operated, cleaned and
maintained, to suit their intended purpose.
Quality management systems should be in place to ensure that these remain in a qualified state throughout their life-cycle and Products should be produced and controlled using qualified equipment and instruments.
Qualification is applicable but are not limited to: certain rooms; water purification systems; cleaning systems; heating, ventilation and air-conditioning systems; compressed air systems; gas systems; and steam systems; as well as production equipment and analytical instruments.
The validation master plan, or other relevant document, should specify the policy, organization, planning, scope and stages applied in qualification on site, and should cover, for example, production, quality control and engineering.
Principles of quality risk management should be applied in qualification which include:
i A clear understanding of the system and the role it plays in establishing/protecting the process and quality, and all of the
potential ways (risks) the process or quality could be impacted by failures, events, errors, or time/use-based factors (deterioration, out of-tolerance instruments, wear and tear, and so on);
¡¡ defining all of the design, procedural and/or quality system controls required to protect against these potential risks. These controls either mitigate/reduce the risks and/or detect the impact to quality or process, should the risk occur (to ensure the failureh does not impact final product quality);
iii compiling evidence during the design, engineering, commissioning and qualification, to demonstrate that all of these required controls have been properly implemented and verified (including function where applicable, such as alarms on operating parameters);
iv appropriate control and oversight of change once the controls have been verified.
- The scope and extent of qualification and re qualification should be determined based on the principles of impact assessment and risk management.
Qualification should be executed by trained personnel. Training records should be maintained.
Where appropriate, new premises, systems, utilities and equipment should be subjected to all stages of qualification. This includes the preparation of user requirements specification (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
Where it is decided that not all stages of qualification are required, justification should be provided.
Qualification should be done in accordance with predetermined and approved qualification protocols. The protocol should specify the prerequisites and test details, including acceptance criteria.
The results of the qualification should be recorded and reflected in qualification reports.
2. Normally, qualification stages should be sequential (e.g. operational qualification should follow after the successful completion of installation qualification). In some cases, different stages of qualification may be executed concurrently. This should be justified and documented in the validation master plan (or qualification protocol).
3. Equipment should be released for routine use only once there is documented evidence that the qualification has been successful.
4. Certain stages of the qualification may be done by a supplier or a third party, subject to the conditions and responsibilities as defined in writing and agreed between the parties. The contract giver remains responsible to ensure that the qualification is done in accordance with the principles of good manufacturing practices.
5. The relevant documentation associated with qualification, including standard operating procedures, specifications and acceptance criteria, certificates and manuals, should be available.
6. Utilities and equipment should be maintained in a qualified state and should be periodically reviewed for the need for requalification and Re qualification should be considered when changes are made.
User requirements specification
URS documentation should be prepared for, but not limited to, utilities and equipment, as appropriate.
URS should be used at later stages in qualification, to verify that the purchased and supplied utility or equipment is in accordance with the user’s needs.
DQ should demonstrate that the system, as designed, is appropriate for its intended use as defined in the URS.
A suitable supplier should be selected and approved for the relevant utility or equipment.
Factory acceptance test and site acceptance test
Where a utility or equipment is assembled, or partially assembled at a site other than that of the purchaser or end-user, testing and verification may be done, based on principles of quality risk management, to ensure that it is appropriate, as described in the URS, and ready for dispatch.
The checks and tests conducted during the factory acceptance test (FAT) should be recorded.
The acceptability of the assembly and overall status of the utility or equipment should be described in a conclusion of the report for the FAT, prior to shipment.
Tests, based on principles of quality risk management, may be performed to verify the acceptability of the utility or equipment when it is received at the end-user. This is a site acceptance test (SAT).
The results of the tests should be evaluated and the outcome of the acceptability of the utility or equipment should be recorded in the conclusion section of the report for the SAT.
Utilities and equipment should be correctly installed, in an appropriate location.
There should be documented evidence of the installation. This should be in accordance with the IQ protocol, which contains all the relevant details.
IQ should include identification and installation verification of relevant components identified (e.g. services, controls and gauges).
Identified measuring, control and indicating devices, should be calibrated on site, unless otherwise appropriately justified. The calibration should be traceable to national or international standards. Traceable certificates should be available.
Deviations and non-conformances, including those from URS, DQ and acceptance criteria specified and observed during installation, should be recorded, investigated and corrected or justified.
The outcome of the IQ should be recorded in the conclusion of the report, before OQ is started.
Requirements and procedures for operation (or use), calibration, maintenance and cleaning should be prepared before OQ and approved prior to PQ.
Utilities and equipment should operate correctly and their operation should be verified in accordance with an OQ protocol. OQ normally follows IQ but, depending on the complexity of the utility or equipment, it may be performed as a combined installation/operation qualification (IOQ). This should be justified and documented in the validation master plan (or qualification protocol).
OQ should include, but is not limited to, the following:
Tests that have been developed from the knowledge of processes, systems and equipment, to ensure the utility or equipment is operating as designed;
tests over the operating limits.
Training of operators for the utilities and equipment should be provided and training records maintained.
Calibration, cleaning, maintenance, training and related tests and results should be verified to be acceptable.
Deviations and non-conformances observed should be recorded, investigated and corrected or justified.
The results for the verification of operation should be documented in the OQ report.
The outcome of the OQ should be recorded in the conclusion of the report,normally before PQ is started.
PQ should normally follow the successful completion of IQ and OQ. In some cases, it may be appropriate to perform PQ in conjunction with OQ or process validation. This should be justified and documented in the validation master plan (or qualification protocol).
PQ should include, but is not limited to, the following:
tests using production materials, qualified substitutes or simulated products proven to have equivalent behaviour under operating conditions, with batch sizes where appropriate;
tests covering the intended operating range.
Utilities and equipment should consistently perform in accordance with their design specifications and URS. The performance should be verified in accordance with a PQ protocol.
There should be records for the PQ (e.g. a PQ report), to indicate the satisfactory performance over a predefined period of time. Manufacturers should justify the period over which PQ is done.
Periodic review and Re qualification
1. Utilities and equipment should be maintained in a qualified state throughout the life-cycle of the utility or equipment.
2. Utilities and equipment should be reviewed periodically, to confirm that they remain in a qualified state or to determine the need for re qualification.
3. Where the need for re qualification is identified, this should be performed.
4. Principles of risk management should be applied in the review and re qualification and the possible impact of small changes over a period of time should further be considered (such as, through change control).
5. Principles of risk management may include factors such as calibration, verification, maintenance data and other information.
6. The qualification status and periodic re qualification due dates should be documented, for example, in a qualification matrix, schedule or plan.
7. In case a utility or equipment in use is identified that has not been subjected to qualification, a qualification protocol should be prepared where elements of URS, design specifications, operation and performance are verified for acceptability. The outcome of this qualification should be recorded in a report.